Depression, Quality of Life
Conditions
Keywords
Depression, Botulinum toxin, Glabella, Quality of life, Self-steem
Brief summary
The primary objective of this study is to determine the alterations in quality of life and self-esteem after BOTOX® injections in the glabella in depressed and non-depressed patients. The secondary objective of this study are: * to assess wrinkles improvement * to evaluate depressive symptoms using Beck Depression Inventory before and after Botox® injections. * to elucidate that depression is not a contraindication for botulinum toxin injections.
Detailed description
The study consists of two groups: one with diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0) and other without diagnosis of depression. Subjects with depression will be part of group 1. They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist. Subjects with no diagnosis of depression will be part of group 2. Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®, Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment. Four visits will be scheduled. Visit 0 (baseline), Visit 1 (intervention), visit 2 (4 weeks), visit 3 (8 weeks) visit 4 (12 weeks). The scales for the assessment of depressive symptoms, Beck Depression Inventory (BDI), will be applied at visits 1,2,3,4; WHOQOL BREF will be applied at baseline visit and 4. Rosenberg Self-Esteem Scale will be applied in all visits. Photographs will be taken as well as the dermatological evaluation of the wrinkles and folds will be assessed using a 4-points validated Severity Wrinkles Scale, and psychiatric evaluation as well, in both groups.
Interventions
DRUGBotulinum Toxin Type A
Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.
Sponsors
Allergan
Hexsel Dermatology Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female subjects,aged between 25 to 60 years; 2. Subjects diagnosed as having major depression according to the criteria of DSM-IV, MINI International Neuropsychiatric Interview (MINI Brazilian version 5.0.0); 3. Subjects who are being administered a therapeutic dose of an approved, prescribed antidepressant medication (pattern doses of the literature), and have been using mentioned medication at a stable therapeutic dose for at least three months prior to the randomization visit; 4. Subjects with mild (1), moderate (2) or severe (3) glabellar frown lines while at rest according the Severity Wrinkles Scales; 5. Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method; 6. Subjects who had never received botulinum toxin A previously; 7. Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form; 8. Subjects who will be available throughout the duration of the study; 9. Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol; 10. Subjects with Critical appreciation preserved, attested by their assistant psychiatrist (for group1); 11. Subjects who reside with other family members who assume co-responsibility in the study.
Exclusion criteria
1. Subjects whose medical history and physical examination present clinical pathology, as myasthenia gravis, Eaton-Lambert Syndrome, neoplasm, muscular diseases, motor neuron diseases, systemic autoimmune or neurological diseases; 2. Pregnant or women in breastfeeding, or women planning to become pregnant 3. Subjects with suicide risk; 4. Subjects addicted to alcohol or illegal drugs within the last 6 months; 5. Subjects using amino glycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers; 6. Subjects using medications that, in the opinion of the investigator may cause depression, such as beta-blockers, oral corticosteroids and interferon; 7. Subjects who, in the opinion of the investigator, may potentially require psychiatric hospitalization during the course of the study; 8. Subjects with inflammation or active infection in the area to be injected; 9. Subjects with a history of non-adherence to medical treatment, or who demonstrate unwillingness to adhere to the study protocol; 10. The presence of any additional active DSM-IV Axis I diagnosis, or mental retardation; 11. History of psychiatric hospitalization within the past three years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rosenberg Self-Esteem Scale | Baseline, Day 1 (intervention), Week 4, Week 8, Week 12 | Measure of self esteem for research purposes. Ten questions graded from 0 to 3 as described below: Questions 1, 3, 4, 7, 10 0 - Totally agree 1. \- Agree 2. \- Disagree 3. \- Totally disagree Questions 2, 5, 6, 8, 9 3 - Totally agree 2 - Agree 1 - Disagree 0 - Totally disagree The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem. |
| Beck Depression Inventory (BDI) | Baseline, Day 1 (intervention), Week 4, Week 8, Week 12 | BDI is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Each question is graded from 0 to 3. 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WHOQOL-BREF | Baseline, Day 1 (intervention), Week 4, Week 8, Week 12 | The WHOQOL-BREF is a scale for the quality of life assessment developed by the World Health Organization. It is composed by 26 questions graded from 1 to 5. Scoring: 1 to 2.9 - needs improvement 3 to 3.9 - regular 4 to 4.9 - good 5 - very good Question 1 asks about the individual's overall perception of quality of life. Results refer to question 1. |
| Wrinkle Severity Scale (WSS) at Rest | Baseline, Week 4, Week 8, Week 12 | The injection of botulinum toxin type A causes muscle paralysis, reducing facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The WSS is a 4-point validated scale for forehead lines: 0 - None 1. \- Mild 2. \- Moderate 3. \- Severe |
| Wrinkle Severity Scale (WSS) at Maximum Contraction | Baseline, Day 1 (intervention), Week 4, Week 8, Week 12 | The injection of botulinum toxin type A causes muscle paralysis, reducing facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The WSS is a 4-point validated scale for forehead lines: 0 - None 1. \- Mild 2. \- Moderate 3. \- Severe |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Depressed Subjects Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.
Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment. | 25 |
| Non Depressed Subjects Subjects with no diagnosis of depression
Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Depressed Subjects | Total | Non Depressed Subjects |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 7 | 49 years STANDARD_DEVIATION 7 | 48 years STANDARD_DEVIATION 7 |
| Education College | 11 Participants | 20 Participants | 9 Participants |
| Education College (not completed) | 2 Participants | 6 Participants | 4 Participants |
| Education High School | 12 Participants | 22 Participants | 10 Participants |
| Education Middle School | 0 Participants | 2 Participants | 2 Participants |
| Marital status Divorced | 8 Participants | 16 Participants | 8 Participants |
| Marital status Married or steady relationship | 14 Participants | 27 Participants | 13 Participants |
| Marital status Single | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized Fitzpatrick Skin Phototype I Phototype I | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Fitzpatrick Skin Phototype I Phototype II | 7 Participants | 10 Participants | 3 Participants |
| Race/Ethnicity, Customized Fitzpatrick Skin Phototype I Phototype III | 15 Participants | 36 Participants | 21 Participants |
| Race/Ethnicity, Customized Fitzpatrick Skin Phototype I Phototype IV | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Fitzpatrick Skin Phototype I Phototype V | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Fitzpatrick Skin Phototype I Phototype VI | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Brazil | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 25 | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Beck Depression Inventory (BDI)
BDI is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Each question is graded from 0 to 3. 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Population: Per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depressed Subjects | Beck Depression Inventory (BDI) | Day 1 (intervention) | 24.3 units on a scale | Standard Deviation 8.8 |
| Depressed Subjects | Beck Depression Inventory (BDI) | Week 8 | 14.9 units on a scale | Standard Deviation 9.9 |
| Depressed Subjects | Beck Depression Inventory (BDI) | Week 4 | 17.0 units on a scale | Standard Deviation 7.9 |
| Depressed Subjects | Beck Depression Inventory (BDI) | Week 12 | 12.5 units on a scale | Standard Deviation 7.9 |
| Depressed Subjects | Beck Depression Inventory (BDI) | Baseline | 27.4 units on a scale | Standard Deviation 5.2 |
| Non Depressed Subjects | Beck Depression Inventory (BDI) | Week 12 | 4.0 units on a scale | Standard Deviation 3.4 |
| Non Depressed Subjects | Beck Depression Inventory (BDI) | Baseline | 6.7 units on a scale | Standard Deviation 5.5 |
| Non Depressed Subjects | Beck Depression Inventory (BDI) | Day 1 (intervention) | 5.8 units on a scale | Standard Deviation 4.5 |
| Non Depressed Subjects | Beck Depression Inventory (BDI) | Week 4 | 5.3 units on a scale | Standard Deviation 4.1 |
| Non Depressed Subjects | Beck Depression Inventory (BDI) | Week 8 | 4.5 units on a scale | Standard Deviation 4.4 |
Primary
Rosenberg Self-Esteem Scale
Measure of self esteem for research purposes. Ten questions graded from 0 to 3 as described below: Questions 1, 3, 4, 7, 10 0 - Totally agree 1. \- Agree 2. \- Disagree 3. \- Totally disagree Questions 2, 5, 6, 8, 9 3 - Totally agree 2 - Agree 1 - Disagree 0 - Totally disagree The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Population: per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depressed Subjects | Rosenberg Self-Esteem Scale | Day 1 (intervention) | 13.5 units on a scale | Standard Deviation 5 |
| Depressed Subjects | Rosenberg Self-Esteem Scale | Week 8 | 17.1 units on a scale | Standard Deviation 5.9 |
| Depressed Subjects | Rosenberg Self-Esteem Scale | Week 4 | 15.2 units on a scale | Standard Deviation 5.8 |
| Depressed Subjects | Rosenberg Self-Esteem Scale | Week 12 | 16.9 units on a scale | Standard Deviation 6.5 |
| Depressed Subjects | Rosenberg Self-Esteem Scale | Baseline | 13.9 units on a scale | Standard Deviation 5.3 |
| Non Depressed Subjects | Rosenberg Self-Esteem Scale | Week 12 | 24.2 units on a scale | Standard Deviation 4.9 |
| Non Depressed Subjects | Rosenberg Self-Esteem Scale | Baseline | 24.6 units on a scale | Standard Deviation 4.3 |
| Non Depressed Subjects | Rosenberg Self-Esteem Scale | Day 1 (intervention) | 23.3 units on a scale | Standard Deviation 5.3 |
| Non Depressed Subjects | Rosenberg Self-Esteem Scale | Week 4 | 23.5 units on a scale | Standard Deviation 4.9 |
| Non Depressed Subjects | Rosenberg Self-Esteem Scale | Week 8 | 24.4 units on a scale | Standard Deviation 4.6 |
Secondary
WHOQOL-BREF
The WHOQOL-BREF is a scale for the quality of life assessment developed by the World Health Organization. It is composed by 26 questions graded from 1 to 5. Scoring: 1 to 2.9 - needs improvement 3 to 3.9 - regular 4 to 4.9 - good 5 - very good Question 1 asks about the individual's overall perception of quality of life. Results refer to question 1.
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Population: Per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depressed Subjects | WHOQOL-BREF | Day 1 (intervention) | 2.9 units on a scale | Standard Deviation 0.85 |
| Depressed Subjects | WHOQOL-BREF | Week 8 | 3.5 units on a scale | Standard Deviation 0.89 |
| Depressed Subjects | WHOQOL-BREF | Week 4 | 3.6 units on a scale | Standard Deviation 0.6 |
| Depressed Subjects | WHOQOL-BREF | Week 12 | 3.4 units on a scale | Standard Deviation 0.81 |
| Depressed Subjects | WHOQOL-BREF | Baseline | 2.9 units on a scale | Standard Deviation 0.77 |
| Non Depressed Subjects | WHOQOL-BREF | Week 12 | 4.1 units on a scale | Standard Deviation 0.57 |
| Non Depressed Subjects | WHOQOL-BREF | Baseline | 3.9 units on a scale | Standard Deviation 0.49 |
| Non Depressed Subjects | WHOQOL-BREF | Day 1 (intervention) | 4.0 units on a scale | Standard Deviation 0.81 |
| Non Depressed Subjects | WHOQOL-BREF | Week 4 | 4.1 units on a scale | Standard Deviation 0.53 |
| Non Depressed Subjects | WHOQOL-BREF | Week 8 | 4.1 units on a scale | Standard Deviation 0.57 |
Secondary
Wrinkle Severity Scale (WSS) at Maximum Contraction
The injection of botulinum toxin type A causes muscle paralysis, reducing facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The WSS is a 4-point validated scale for forehead lines: 0 - None 1. \- Mild 2. \- Moderate 3. \- Severe
Time frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Population: Per protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depressed Subjects | Wrinkle Severity Scale (WSS) at Maximum Contraction | Baseline | 2.6 units on a scale | Standard Deviation 0.69 |
| Depressed Subjects | Wrinkle Severity Scale (WSS) at Maximum Contraction | Week 4 | 1.1 units on a scale | Standard Deviation 0.64 |
| Depressed Subjects | Wrinkle Severity Scale (WSS) at Maximum Contraction | Week 8 | 0.9 units on a scale | Standard Deviation 0.8 |
| Depressed Subjects | Wrinkle Severity Scale (WSS) at Maximum Contraction | Week 12 | 1.4 units on a scale | Standard Deviation 0.7 |
| Non Depressed Subjects | Wrinkle Severity Scale (WSS) at Maximum Contraction | Week 12 | 1.7 units on a scale | Standard Deviation 0.56 |
| Non Depressed Subjects | Wrinkle Severity Scale (WSS) at Maximum Contraction | Baseline | 2.7 units on a scale | Standard Deviation 0.48 |
| Non Depressed Subjects | Wrinkle Severity Scale (WSS) at Maximum Contraction | Week 8 | 1.2 units on a scale | Standard Deviation 0.8 |
| Non Depressed Subjects | Wrinkle Severity Scale (WSS) at Maximum Contraction | Week 4 | 1.2 units on a scale | Standard Deviation 0.65 |
Secondary
Wrinkle Severity Scale (WSS) at Rest
The injection of botulinum toxin type A causes muscle paralysis, reducing facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The WSS is a 4-point validated scale for forehead lines: 0 - None 1. \- Mild 2. \- Moderate 3. \- Severe
Time frame: Baseline, Week 4, Week 8, Week 12
Population: Per protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Depressed Subjects | Wrinkle Severity Scale (WSS) at Rest | Baseline | 1.6 units on a scale | Standard Deviation 0.76 |
| Depressed Subjects | Wrinkle Severity Scale (WSS) at Rest | Week 4 | 0.4 units on a scale | Standard Deviation 0.61 |
| Depressed Subjects | Wrinkle Severity Scale (WSS) at Rest | Week 8 | 0.4 units on a scale | Standard Deviation 0.62 |
| Depressed Subjects | Wrinkle Severity Scale (WSS) at Rest | Week 12 | 0.4 units on a scale | Standard Deviation 0.62 |
| Non Depressed Subjects | Wrinkle Severity Scale (WSS) at Rest | Week 12 | 0.7 units on a scale | Standard Deviation 0.58 |
| Non Depressed Subjects | Wrinkle Severity Scale (WSS) at Rest | Baseline | 1.5 units on a scale | Standard Deviation 0.51 |
| Non Depressed Subjects | Wrinkle Severity Scale (WSS) at Rest | Week 8 | 0.4 units on a scale | Standard Deviation 0.58 |
| Non Depressed Subjects | Wrinkle Severity Scale (WSS) at Rest | Week 4 | 0.5 units on a scale | Standard Deviation 0.59 |